Disrupted Sleep in Somali Americans - Implications for Hypertension Risk
| Registry | NCT05411029 |
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| Status | Recruiting |
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| Study type | Observational |
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| Enrollment | 240 (Estimated) |
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| Sponsor | Mayo Clinic (Other); collaborators: National Heart, Lung, and Blood Institute (NHLBI) |
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| Conditions | Hypertension, Sleep Disorder, Healthy |
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| Interventions | 24 hour blood pressure (BP) monitoring, Polysomnography (Diagnostic test) |
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| Dates | start 2022-11-15, primary completion 2028-10-01 (estimated), completion 2028-10-01 (estimated), first posted 2022-06-08, last updated 2026-09-14 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Hypertension All trials for Sleep Disorder All trials of 24 hour blood pressure (BP) monitoring All trials of Polysomnography
-Summary
The aims of this study are to determine the types and severity of previously undiagnosed sleep deficiencies in otherwise healthy Somali Americans, apply a research framework to define psychosocial, behavioral, environmental, and biological mechanisms mediating sleep deficiencies in Somali Americans, and examine the relationship between sleep deficiencies and increased blood pressure in Somali Americans.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Healthy Somali Americans | | Diagnostic Test: 24 hour blood pressure (BP) monitoring; Diagnostic Test: Polysomnography | Somali Americans with no known history of hypertension, diabetes, or sleep disorders will have a 24 hour blood pressure monitoring and polysomnography. |
- 24 hour blood pressure (BP) monitoring (Diagnostic test): 24-hour ambulatory BP measuring device and blood pressures will be measured every 20 minutes to half hour
- Polysomnography (Diagnostic test), also known as Sleep Study: Measurements will include electroencephalogram, electromyogram, electrooculogram, electrocardiogram, breathing patterns of chest and abdomen, nasal and oral airflow and oxygen saturation. Sleep stages and apneas will be scored in accordance with validated American Academy of Sleep Medicine standards.
+Outcome measures
Primary outcomes
- Undiagnosed sleep deficiency-short sleep [1 night sleep study, approximately 8-9 hours]: Number of subjects to have short sleep (<6 hours) as measured by the sleep study
- Undiagnosed sleep deficiency-insomnia [1 night sleep study, approximately 8-9 hours]: Number of subjects to have insomnia as measured by the sleep study
- Undiagnosed sleep deficiency-obstructive sleep apnea (OSA) [1 night sleep study, approximately 8-9 hours]: Number of subjects to have OSA as measured by the sleep study
- Disrupted sleep [1 night sleep study, approximately 8-9 hours]: Number of subjects to have disrupted sleep as measured by the sleep study
- Blood pressure (BP) during wakefulness [Day 2]: Average BP as measured by 24 hour BP monitoring, reported in mmHg
- Blood pressure (BP) during sleep [Day 2]: Average BP as measured by 24 hour BP monitoring, reported in mmHg
+Eligibility
Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers
Inclusion Criteria:
* Subjects diagnosed with no known history of hypertension, diabetes, or sleep disorders.
* Self-identify as Somali.
* Adult males and females who are older than 18 years of age.
Exclusion Criteria:
* Anyone under 18 years or over 70 years.
* Positive pregnancy.
+Locations (1)
| Facility | City | Country | Status |
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| Mayo Clinic in Rochester | Rochester, Minnesota | United States | Recruiting |
+Publications
- Results publication: Greenlund IM, Bock JM, Govindan N, Kantas D, Singh P, Covassin N, Somers VK. Blood Pressure and Heart Rate Response to Orthostasis in Somali Americans. J Racial Ethn Health Disparities. 2026 Jun;13(3):1961-1966. doi: 10.1007/s40615-025-02389-7. Epub 2025 Mar 15. PMID 40088388
- Results publication: Greenlund I, Bock J, Govindan N, Kantas D, Singh P, Covassin N, Somers V. Blood Pressure and Heart Rate Response to Orthostasis in Somali Americans. Res Sq [Preprint]. 2024 Oct 21:rs.3.rs-4925722. doi: 10.21203/rs.3.rs-4925722/v1. PMID 39502777
+Investigators
+Funding